RecruitingNANCT07510698

Evaluation of Safety, Quality of Life, Cost and Environmental Impact of Day Surgery in Mastectomy and Prepectoral Reconstruction - Awake MAstectomy in Day Surgery With Immediate Prepectoral Implant Reconstruction and Muscle Sparing

Sponsor: University of Rome Tor Vergata

Trial Details

ConditionBreast Cancer, Mastectomy, Prepectoral Breast Reconstruction, ERAS Programmes
InterventionAMADeuS Perioperative Pathway; Usual Perioperative Care
PhaseNA
StatusRecruiting
Participants100
Est. Completion1 Mar 2028
Last Updated3 Apr 2026

Primary Outcome

Postoperative pain at rest over 48 hours; Major Postoperative Safety Composite at 30 days

Eligibility Criteria

Inclusion Criteria

\*\*Inclusion Criteria:\*\* * Biologically female participants aged 18 to 75 years * Oncologic or prophylactic indication for nipple-sparing mastectomy or skin-sparing mastectomy with immediate prepectoral reconstruction using a definitive implant or tissue expander, including early breast cancer or a high-risk genetic condition such as BRCA * Eligible for prepectoral reconstruction based on clinico-anatomic criteria, including adequate skin flap thickness, no relevant vascular compromise, body mass index less than 35, and no severe prior chest radiotherapy * American Society of Anesthesiologists (ASA) class I to III * Eligible for day surgery, defined by home autonomy, caregiver availability during the first 24 hours after surgery, and distance from the hospital compatible with home management * Able and willing to complete telemedicine follow-up, including completion of protocol-required patient-reported outcome measures * Written informed consent provided \*\*Exclusion Criteria:\*\* * Chronic opioid use or treatment for pre-existing chronic pain that could interfere with assessment of the primary postoperative pain endpoint * Contraindications to locoregional anesthesia techniques or to the awake/monitored anesthesia care protocol, including allergy to local anesthetics, coagulation disorders, or inability to cooperate during surgery * Body mass index 35 or greater, or anatomic conditions contraindicating prepectoral reconstruction * Previous high-dose chest radiotherapy with significant tissue compromise * Pregnancy or breastfeeding * Inability to guarantee planned follow-up or lack of adequate home support * Psychiatric or cognitive conditions preventing correct completion of patient-reported outcome measures

Trial Sites

Countries

Italy
View Registry Entry

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